In support of the application to the Medicines and Healthcare products Regulatory Agency (MHRA) to extend the Exceptional Use Authorisation (EUA) for COVID-19 lateral flow tests, the Department submitted an extension request which relied on the documentation provided in the initial EUA submission and a preliminary performance analysis on repeat and one off testing.
Instructions for use and packaging formed part of this application, both of which can be found in the NHS Test and Trace COVID-19 Self-Test kit.
A number of scientific publications were also considered in the initial application to award an EUA and links to these can be found below:
- Estimating the extent of asymptomatic COVID-19 and its potential for community transmission: systematic review and meta-analysis: https://jammi.utpjournals.press/doi/10.3138/jammi-2020-0030
- Paper: Covid-19: Innova lateral flow test is not fit for “test and release” strategy, say experts: https://www.bmj.com/content/371/bmj.m4469
- Research article: Differential occupational risks to healthcare workers from SARS-CoV-2 observed during a prospective observational study: https://pubmed.ncbi.nlm.nih.gov/32820721/
- Article: Duration of infectiousness and correlation with RT-PCR cycle threshold values in cases of COVID-19, England, January to May 2020: https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.32.2001483
- Results of the SAFE School Hesse Study: https://www.medrxiv.org/content/10.1101/2020.12.04.20243410v1
- Quantifying SARS-CoV-2 transmission suggests epidemic control with digital contact tracing: https://science.sciencemag.org/content/368/6491/eabb6936
- Effectiveness of isolation, testing, contact tracing, and physical distancing on reducing transmission of SARS-CoV-2 in different settings: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30457-6/fulltext
- SARS-CoV-1 2 viral dynamics in acute infections: https://www.medrxiv.org/content/10.1101/2020.10.21.20217042v2
- Test sensitivity is secondary to frequency and turnaround time for COVID-19 surveillance: https://www.medrxiv.org/content/10.1101/2020.06.22.20136309v3
- Rapid testing strategies for traced contacts: comparing quarantine, quarantine and testing, and repeat daily testing: https://cmmid.github.io/topics/covid19/daily_testing.html
- Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected anterior nasal swab versus professional collected nasopharyngeal swab: https://www.medrxiv.org/content/10.1101/2020.10.26.20219600v1
- Rethinking Covid-19 Test Sensitivity — A Strategy for Containment: https://www.nejm.org/doi/full/10.1056/nejmp2025631
The MHRA also asked as part of their conditions that lateral flow device performance data from October 2020 to May 2021 would be provided and published as soon as possible. This is available at the following link: